Label: UMECTA MOUSSE UREA- urea foam aerosol, foam

  • NDC Code(s): 68712-020-01
  • Packager: Innocutis Holdings LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 23, 2011

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  • Description

    Rx only
    For topical use only
    Not for ophthalmic use


    Umecta is a keratolytic, emollient which is a gentle, yet potent, tissue softener for nails and skin Each gram of Umecta mousse contains urea (40%), Butane, Butyrospermum Parkii (Shea Butter) Extract, Carbomer, Glycine Soya (Soy Bean) Sterol, Helianthus Annuus (Sunflower) Oil, Isobutane, Laureth-4, Polysorbate-20, Propane, Purified Water, Stearic Acid, Triethanolamine. Urea is a diamide of carbonic acid with the following chemical structure:




    Image of chemical Structure


  • Clinical Pharmacology


    Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate which can result in the softening and eventual debridement of the nail plate.
  • Pharmacokinetics

    The mechanism of action of topically applied urea is not yet known.

  • Indications and Usage

    For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns, and calluses, as well as damaged, ingrown and devitalized nails.

  • Contraindications

    Known hypersensitivity to any of the listed ingredients.
  • Warnings

    For external use only. Avoid contact with eyes, lips or mucous membranes. Umecta Mousse canister - contents under pressure do not puncture or incinerate. Do not store at temperatures above 120º F.

  • Precautions

    This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.
  • Pregnancy

    Animal reproduction studies have not been conducted with Umecta. It is also not known whether Umecta can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Umecta should be given to a pregnant woman only if clearly needed.
  • Nursing Monthers

    It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Umecta is administered to a nursing woman.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

  • Adverse Reactions

    Transient stinging, burning, itching, or irritation may occur and normally disappear on discontinuing the medication.

  • Dosage and Administration

    Apply Umecta PD bioadhesive emulsion/topical suspension or Umecta mousse to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed

  • How Supplied

    Umecta (urea, 40%) mousse is available in a: 4 oz. can NDC 68712-020-01

    Store at controlled room temperature 15-30°C (59-86°F).

    Protect from freezing.

    Manufactured for:

    Innocutis Holdings LLC
    Charleston, SC 29401
    Toll Free: 1-800-499-4468
    www.innocutis.com
    www.umecta.com

  • PRINCIPAL DISPLAY PANEL





    Label

  • INGREDIENTS AND APPEARANCE
    UMECTA MOUSSE  UREA
    urea foam aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68712-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTANE (UNII: 6LV4FOR43R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARBOMER 934 (UNII: Z135WT9208)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ISOBUTANE (UNII: BXR49TP611)  
    LAURETH-4 (UNII: 6HQ855798J)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPANE (UNII: T75W9911L6)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68712-020-01113.4 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/01/2007
    Labeler - Innocutis Holdings LLC (071501252)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Spraytech LLC137135237manufacture